SLC Breast Consensus Press Release, 09_16

PHILADELPHIA, September 16, 2008 – A panel of leading breast cancer experts has identified and prioritized 13 late-stage, or Phase 3, breast cancer research studies from a total of more than 515 currently underway, with the greatest potential to improve treatment and survival.

The 21 experts, all members of the Coalition of Cancer Cooperative Group’s Scientific Leadership Council (SLC) in Breast Cancer outlined their consensus -- Research Priorities in Breast Cancer: Recommendations of the Scientific Leadership Council in Breast Cancer of the Coalition of Cancer Cooperative Groups -- at a meeting of physicians, researchers, patient advocates, government and industry representatives in Dallas September 12-13, and urged physicians to enroll as many of their eligible patients into the trials as possible. The SLC in Breast Cancer was chaired by Julie Gralow, MD, associate professor, University of Washington School of Medicine, and Director, Breast Medical Oncology at UW’s Seattle Cancer Care Alliance and Edith Perez, MD, Director of the Breast Cancer Program, Division of Hematology/Oncology, and Department of Internal Medicine at the Mayo Clinic in Jacksonville, Florida.

Together, the priority studies require patient enrollment of nearly 43,500. To date, about 17,400 patients have been enrolled, leaving more than 26,000 patients still needed for these studies. Enrollment of breast cancer patients in publicly funded studies averages about 9,300 annuallyⁱ; the number of breast cancer patients on privately funded studies is not known. More rapid enrollment and timely completion of these studies can quicken the pace of diagnostic and treatment advances by resolving clinical questions such as:

How to predict the impact of biological effects of chemopreventive agents with the development and validation of new, clinically relevant biomarkers
How to design, select – and afford - individualized cancer therapy in an era of escalating costs for biologic treatments
How, when and whether to use chemotherapy in breast cancer treatment for some patients
How to best incorporate novel approaches, including biophosphonates in breast cancer treatment to reduce the risk of bone metastases
How best to address the growing issue of long term neurotoxic and cognitive side effects in breast cancer survivors
How to design clinical trials that can be completed more efficiently including randomized discontinuation trials or "adaptive" trial designs that require fewer patients and/or shorter study duration.

Six of the studies are for patients with early-stage breast cancer, three are studies investigating the use of drugs to shrink tumors or eliminate cancer cells prior to surgery, two are in advanced breast cancer, one focuses on quality of life, and one on effectiveness of partial over whole breast irradiation. A molecular/genetic profiling study will determine whether some women typically treated with chemotherapy in addition to hormonal therapy based on clinical characteristics may not need chemotherapy.

Breast cancer remains the most common malignancy in women in the U.S. and is the second most common cause of cancer death. In 2008, it is estimated that 182,460 new cases of invasive and 67,770 cases of in situ breast cancer will be diagnosed in women and 40,480 women will die from the disease.

The SLC also emphasized the importance of connecting patients to priority trial information. Research conducted by the Coalition and Northwestern University shows that only 15 percent of all breast cancer patients are aware of the clinical trial option at time of diagnosis. The Coalition’s TrialCheck®, Internet-based cancer clinical trial navigation and matching system of all federally registered cancer studies, is designed to help close this information gap by electronically linking patients to hospitals and practices near their home offering cancer clinical trials relevant to the patient’s individual medical needs.

Coalition of Cancer Cooperative Groups
1818 Market Street, Suite 1100, Philadelphia, PA 19103 (215) 789-3600
www.CancerTrialsHelp.org

ⁱBaseline Study of Patient Accrual onto Publicly Sponsored US Cancer Clinical Trials: An Analysis Conducted for the Global Access Project of the National Patient Advocate Foundation. Coalition of Cancer Cooperative Groups, Philadelphia, PA. February 1, 2006 (Study Period: 01/01/03 – 06/30/05).


Contact: Diane D. Colaizzi Media Relations (215) 789-3612 dcolaizzi@CancerTrialsHelp.org	Pat Garrison Media Relations (973) 313-0554 patgarrison@optonline.net
Breast Cancer Treatment: Leading Experts Identify Highest Research Priorities; Urge Rapid Patient Enrollment into Studies with the Greatest Potential to Improve Treatment and Survival
PHILADELPHIA, September 16, 2008 – A panel of leading breast cancer experts has identified and prioritized 13 late-stage, or Phase 3, breast cancer research studies from a total of more than 515 currently underway, with the greatest potential to improve treatment and survival. The 21 experts, all members of the Coalition of Cancer Cooperative Group’s Scientific Leadership Council (SLC) in Breast Cancer outlined their consensus -- Research Priorities in Breast Cancer: Recommendations of the Scientific Leadership Council in Breast Cancer of the Coalition of Cancer Cooperative Groups -- at a meeting of physicians, researchers, patient advocates, government and industry representatives in Dallas September 12-13, and urged physicians to enroll as many of their eligible patients into the trials as possible. The SLC in Breast Cancer was chaired by Julie Gralow, MD, associate professor, University of Washington School of Medicine, and Director, Breast Medical Oncology at UW’s Seattle Cancer Care Alliance and Edith Perez, MD, Director of the Breast Cancer Program, Division of Hematology/Oncology, and Department of Internal Medicine at the Mayo Clinic in Jacksonville, Florida. Together, the priority studies require patient enrollment of nearly 43,500. To date, about 17,400 patients have been enrolled, leaving more than 26,000 patients still needed for these studies. Enrollment of breast cancer patients in publicly funded studies averages about 9,300 annuallyⁱ; the number of breast cancer patients on privately funded studies is not known. More rapid enrollment and timely completion of these studies can quicken the pace of diagnostic and treatment advances by resolving clinical questions such as: How to predict the impact of biological effects of chemopreventive agents with the development and validation of new, clinically relevant biomarkers How to design, select – and afford - individualized cancer therapy in an era of escalating costs for biologic treatments How, when and whether to use chemotherapy in breast cancer treatment for some patients How to best incorporate novel approaches, including biophosphonates in breast cancer treatment to reduce the risk of bone metastases How best to address the growing issue of long term neurotoxic and cognitive side effects in breast cancer survivors How to design clinical trials that can be completed more efficiently including randomized discontinuation trials or "adaptive" trial designs that require fewer patients and/or shorter study duration. Six of the studies are for patients with early-stage breast cancer, three are studies investigating the use of drugs to shrink tumors or eliminate cancer cells prior to surgery, two are in advanced breast cancer, one focuses on quality of life, and one on effectiveness of partial over whole breast irradiation. A molecular/genetic profiling study will determine whether some women typically treated with chemotherapy in addition to hormonal therapy based on clinical characteristics may not need chemotherapy. Breast cancer remains the most common malignancy in women in the U.S. and is the second most common cause of cancer death. In 2008, it is estimated that 182,460 new cases of invasive and 67,770 cases of in situ breast cancer will be diagnosed in women and 40,480 women will die from the disease. The SLC also emphasized the importance of connecting patients to priority trial information. Research conducted by the Coalition and Northwestern University shows that only 15 percent of all breast cancer patients are aware of the clinical trial option at time of diagnosis. The Coalition’s TrialCheck®, Internet-based cancer clinical trial navigation and matching system of all federally registered cancer studies, is designed to help close this information gap by electronically linking patients to hospitals and practices near their home offering cancer clinical trials relevant to the patient’s individual medical needs. Coalition of Cancer Cooperative Groups 1818 Market Street, Suite 1100, Philadelphia, PA 19103 (215) 789-3600 www.CancerTrialsHelp.org ⁱBaseline Study of Patient Accrual onto Publicly Sponsored US Cancer Clinical Trials: An Analysis Conducted for the Global Access Project of the National Patient Advocate Foundation. Coalition of Cancer Cooperative Groups, Philadelphia, PA. February 1, 2006 (Study Period: 01/01/03 – 06/30/05).